Cataract Surgery
Conditions
Keywords
Music, cataract surgery, topical anaesthesia, anxiety, hypertension
Brief summary
The purpose of the study is to assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures performed under topical anaesthesia.
Detailed description
Cataract surgery is the most frequent surgical procedure performed in Europe, usually done under topical anaesthesia. Restlessness and hypertension are the most frequent medical complications during surgery, potentially leading to surgical complications. Since the surgery is ambulatory and requires the patient's cooperation, heavy intravenous sedation should be avoided. However, this procedure is stressful, with patients experiencing high anxiety due to being awake and aware of the procedure on their eye and equipment. Music therapy may be considered as a non-pharmacologic and non-invasive mean to reduce anxiety and therefore intra-operative hypertension. To assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures under topical anaesthesia, investigators intend to perform a randomized controlled trial. Depending on the results of the study, music therapy may subsequently be replacing the usual premedication before surgery.
Interventions
OTHERMusic
headphones with music
OTHERNo Music
headphones without music
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective cataract surgery performed under topical anaesthesia
Exclusion criteria
* Non topical anaesthesia * Non ambulatory surgery * Communication difficulties including language barrier, and mental disorders * Age\<18yo * Hearing impairment * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypertensive event | Intraoperative every 5 minutes | Non invasive measure through blood pressure cuff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety score before surgery | before surgery | on a visual analogue scale |
| Anxiety score after surgery | after surgery | on a visual analogue scale |
| Duration of surgery | after surgery | — |
| Intraoperative surgical complications | during surgery | reported by surgeon |
Countries
France
Outcome results
None listed